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PF-06821497 (pf-06821497)
PF-06821497 (generic name: pf-06821497) is a drug developed by Pfizer Inc.. It is currently in Phase 3 development.
PF-06821497 is a small molecule used in clinical trials for various prostate cancer conditions, including Metastatic Castrate Resistant Prostate Cancer (mCRPC), Prostate Cancer (Adenocarcinoma), and Metastatic Castration Sensitive Prostate Cancer (mCSPC). It has been studied in combination with Enzalutamide in a Phase 2 clinical trial for patients who have previously received Androgen Receptor Pathway Inhibitor therapy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | pf-06821497 |
|---|---|
| Sponsor | Pfizer Inc. |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
- Headache
- Vessel puncture site bruise
- Nail avulsion
- Neck pain
- Disturbance in attention
- Eyelid pain
- abdominal discomfort
- Abdominal pain
- Constipation
- Nausea
- Vessel puncture site pain
- Fall
Key clinical trials
- A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. (PHASE3)
- A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma (PHASE1)
- This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. (PHASE3)
- A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). (PHASE3)
- A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants. (PHASE1)
- A Study to Learn How Different Tablets of the Study Medicine Mevrometostat Are Taken up Into the Blood in Healthy Adults (PHASE1)
- A Study to Learn How the Medicine Called [14C] PF-06821497 is Taken up Into and Removed From the Body. (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- PF-06821497 CI brief — competitive landscape report
- PF-06821497 updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about PF-06821497
What is PF-06821497?
Who makes PF-06821497?
What is the generic name of PF-06821497?
What development phase is PF-06821497 in?
What are the side effects of PF-06821497?
Related
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing